Format

Send to

Choose Destination
N Engl J Med. 2019 May 16;380(20):1906-1917. doi: 10.1056/NEJMoa1813959.

Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source.

Collaborators (604)

Diener HC, Sacco R, Easton JD, Granger C, Cronin L, Grauer C, Cotton D, Uchiyama S, Bernstein R, Estol C, Bahit C, Donnan G, Brainin M, Lemmens R, Martins S, Silver F, Illanes S, Wang Y, Munoz M, Poljakovic Z, Sanak D, Korv J, Leys D, Grond M, Tsivgoulis GK, Wong LKS, Csiba L, Srivastava MVP, Bornstein N, Toni D, Toyoda K, Lee BC, Basri HB, Villareal-Careaga J, Barrientos Iman DM, Abanto Argomedo SC, Stepien A, Ferro J, Odinak M, Beslac-Bumbasirevic L, Chang HM, Gdovinova Z, Zvan B, Coetzee C, Masjuan J, Sjostrand C, Lyrer P, Liou CW, Suwanwela NC, Uzuner N, Mishchenko T, Saver J, Makuch R, Lees K, Kirchhof P, Von Kummer R, Tijssen JGP, Schuetz F, Mattle H, Tai WA, Caso V, Caplan L, Januzzi J, Mahaffey K, Miller A, Lopes R, Zurru MC, Klein F, Caccavo A, Lorenzatti A, Ioli P, Bladin C, Krause M, Kleinig T, Grimley R, Spratt N, Davis S, Lee A, Delcourt C, Wong A, Sturm J, Cloud G, Markus R, Thijs V, Eggers C, Daniel G, Haring HP, Knoflach M, Yilmaz-Kaymaz N, Vosko M, Niederkorn K, Baumgartner C, Vanhee F, Peeters A, Mairesse G, Desfontaines P, Laloux P, Hemelsoet D, Blauwe S, Hasenbroekx MC, De Vooght W, Gazagnes MD, Mulleners E, Van Landegem W, Rutgers M, Vieren M, Moro CH, Bazan R, Zetola V, Pontes Neto O, Freitas G, Verreault S, Odier C, Moreau F, Hachinski V, Shuaib A, Boulanger JM, Ehrensperger E, Selchen D, Buck B, Coutts S, Beaudry M, Blacquiere D, Eustace M, Pesant Y, Tamayo A, Castro A, Rivas R, Lu X, Chen H, Feng J, Tan L, Lou M, Geng D, Zhang Z, Xu P, Wu Z, Hu X, Yin X, Xu A, Pan X, Nie Z, Ma Q, Wang X, Dong Q, Li Y, Xu Y, Zhang Y, Fan D, Triana J, Silva F, Arias F, Malojcic B, Kidemet Piskac S, Basic Kes V, Bar M, Reif M, Skoda O, Kalina M, Vaclavik D, Sarbochova I, Gross-Paju K, Schneider S, Zjablov G, Sibon I, Nighoghossian N, Touze E, Timsit S, Moulin T, Di Legge S, Ducrocq X, Larrue V, Ellie E, Calvet D, Detante O, Zuber M, Schellinger P, Kallmunzer B, Marquardt L, Krause L, Pohlmann C, Soda H, Nabavi DG, Pfeilschifter W, Butscheid F, Berrouschot J, Ringleb PA, Roether J, Poli S, Groeschel K, Dziewas R, Reimann G, Weissenborn K, Faiss JH, von Mering M, Neumann-Haefelin T, Goertler M, Schaebitz WR, Schellong S, Althaus K, Hamann G, Schmid E, Schlachetzki F, Heide W, Thomalla G, Terborg C, Schubert R, Weber R, Sass C, Nuckel M, Puetz V, Oelschlaeger C, Witte OW, Meyne J, Siedow A, Tanislav C, Kermer P, Michalski D, Kerth HM, Dzialowski I, Knake S, Kellert L, Jauss JM, Maschke M, Steinke W, Jander S, Onur OA, Gaida B, Kuhnlein P, Haase CG, Huber R, Gass S, Opherk C, Schwarze JJ, Fluri F, Steiner T, Malessa R, Krogias C, Wunderlich S, Haensch CA, Schwenkreis P, Thonke S, Kastrup A, Eicke M, Tsivgoulis G, Karapanayiotides T, Tavernarakis A, Ellul I, Dardiotis E, Vadikolias K, Mitsias P, Wong KS, Chang RSK, Li R, Komoly S, Panczel G, Ovary C, Bereczki D, Pauker Z, Csiba L, Borgohain R, Khurana D, Vijaya P, Sundar U, Joseph S, Nellikunja S, Srivastava MVP, Sarma GRK, Udar M, Baviskar R, Tanne D, Hallevi H, Sabetay S, Zini A, Roveri L, Delodovici M, Guidetti D, Tassinari T, Tassi R, Baracchini C, Magoni M, Anticoli S, De Vito A, Imperiale D, Guarino M, Rasura M, Di Lazzaro V, Adobbati L, Agnelli G, Serrati C, Tonello S, Musolino R, Micheletti N, Carolei A, Cerrato P, Hagihara Y, Kuwashiro T, Kamiyama K, Mori T, Nakagawa H, Fukuyama K, Akaike Y, Go Y, Kin S, Imamura E, Uenohara H, Kaku Y, Ishibashi Y, Kitagawa K, Tsuboi Y, Takenaka K, Ito Y, Osaki M, Matsumoto H, Sato A, Tsutsumi M, Goda R, Kikui S, Yoshida H, Terasaki T, Hirano T, Matsuoka H, Nishiyama Y, Kusano Y, Naka T, Ota M, Sakai H, Saito S, Sakai N, Naka H, Arai H, Nakase T, Shimooka N, Watanabe M, Naka Y, Hitotsumatsu T, Takahashi A, Sato M, Taniguchi H, Yonehara T, Umemura T, Tomosugi T, Kanzawa T, Takao M, Fukushima Y, Nakamoto H, Oki S, Osada H, Tsujino A, Tomimitsu H, Mochizuki H, Asakura K, Kawaba T, Uemura K, Inoha S, Hashimoto Y, Sato H, Nishina Y, Heo JH, Koo J, Bang OY, Kwon SU, Bae HJ, Ahn SH, Park MS, Lee JH, Hwang YH, Oh K, Lee YS, Cha JK, Hong KS, Park KY, Hong JM, Jeong HS, Looi I, Aziz Z, Law W, Villarreal J, Gongora J, Cantu-Brito C, Rodriguez I, Leal R, Lanford J, Barber A, Singh J, Abanto S, Cotrina R, Chrzanowska-Wasko J, Kobielusz-Gembala I, Sobolewski P, Szczudlik A, Dylewicz L, Krzak-Kubica A, Rejdak K, Domzal-Stryga A, Bonek R, Cruz V, Roriz J, Inacio N, Fonseca L, Fonseca C, Rodrigues M, Ferreira C, Lopes G, Silva F, Baptista M, Salgado V, Nunes A, Chernyatina M, Timchenko L, Kovalchuk E, Shvarts Y, Belkin A, Khasanova D, Maslova N, Vasilieva E, Schukin I, Doronina O, Vorobyeva O, Guekht A, Zarkov M, Zidverc-Trajkovic J, Zivkovic M, Savic M, Chan B, Singh R, Brozman M, Gdovinova Z, Sostaric Podlesnik M, Menih M, Moodley R, Kakaza M, Krupinski J, Molina C, Lainez JM, Rodriguez M, Segura T, Purroy F, Zabaleta MM, Diez Tejedor E, Rodriguez A, Moniche F, Arenillas JF, Ustrell X, Serena J, Egido JA, Ximenez-Carrillo A, Gil-Nunez A, Marti Fabregas J, Aymerich N, Jimenez C, Karlsson JE, Laska AC, Cederin B, Kostulas K, Dellborg M, Lyrer P, Kagi G, Michel P, Cereda C, Nedeltchev K, Luft A, Arnold M, Lee TH, Po HL, Chen CH, Lin HJ, Chen PL, Chen CM, Lee JT, Liu CH, Jeng JS, Lin RT, Yin JH, Sun MC, Chutinet A, Nilanont Y, Samintharapanya K, Keandoungchun J, Gungor L, Arsava M, Yesilot N, Isikay CT, Soysal A, Goksan B, Kolukisa M, Yayla V, Kutluk K, Turgut N, Midi I, Tanriverdi Z, Nazliel B, Smolko N, Dubenko O, Shkrobot S, Kuznetsova S, Sanotskyy Y, Pryshchepa V, Pashkovskyy V, Sethi P, Singhal A, Sangha N, Milling T, Caprio F, Lee L, Rayes M, Lepor N, Nichols F, Rose D, Siddiqui F, Saad A, Fayad P, Hake A, Chiu D, Conners J, Owada K, Alexandrov A, Malek A, Graffagnino C, Sharaf A, Welker J, Mallenbaum S, Mueller-Kronast N, Goldstein M, Felton W, Young M, Gzesh D, Katz J, Ip J, Hussein H, Yapundich R, Farooq M, Bradbury E, Wang D, Meisel K, Finkielstein D, Koch S, Katramados A, Zweifler R, Lutsep H, McIntosh G, Salem R, Tabbaa M, Kumar A, Khan M, Lee V, Shafer S, Rajan R, Skalabrin E, Remmel K, Reichwein R, LaFranchise EF, Nolte J, Sher A, Kaushal R, Kale S, Pappas C, Anderson G, Rordorf G, Brorson J, Ania R, Blankenship L, Freiberg J, Jaffrani N, Shah N, McDaneld L, Serota H, Dihenia B, Xavier A, Porth K, Nouh A, Tamulonis D, Sharma L, Modir R, Khan A, Jarquin-Valdivia A, Majjhoo A, Darkhabani Z, Harris J, Jacoby M, Commichau C, Rasheed A, Jones W, Lioutas V, Mack A, Tzeng D, French B, Stahl J, Yasen J, Patel N, Shafran B, Wagner J, Mohammad A, Hamroff G, Chaturvedi S, Puente M, Boutwell C, Ohanian A, Lupovitch S, Heiman-Patterson T, Juang G, Almousalli O, Colley BJ, El Husseini N.

Abstract

BACKGROUND:

Cryptogenic strokes constitute 20 to 30% of ischemic strokes, and most cryptogenic strokes are considered to be embolic and of undetermined source. An earlier randomized trial showed that rivaroxaban is no more effective than aspirin in preventing recurrent stroke after a presumed embolic stroke from an undetermined source. Whether dabigatran would be effective in preventing recurrent strokes after this type of stroke was unclear.

METHODS:

We conducted a multicenter, randomized, double-blind trial of dabigatran at a dose of 150 mg or 110 mg twice daily as compared with aspirin at a dose of 100 mg once daily in patients who had had an embolic stroke of undetermined source. The primary outcome was recurrent stroke. The primary safety outcome was major bleeding.

RESULTS:

A total of 5390 patients were enrolled at 564 sites and were randomly assigned to receive dabigatran (2695 patients) or aspirin (2695 patients). During a median follow-up of 19 months, recurrent strokes occurred in 177 patients (6.6%) in the dabigatran group (4.1% per year) and in 207 patients (7.7%) in the aspirin group (4.8% per year) (hazard ratio, 0.85; 95% confidence interval [CI], 0.69 to 1.03; P = 0.10). Ischemic strokes occurred in 172 patients (4.0% per year) and 203 patients (4.7% per year), respectively (hazard ratio, 0.84; 95% CI, 0.68 to 1.03). Major bleeding occurred in 77 patients (1.7% per year) in the dabigatran group and in 64 patients (1.4% per year) in the aspirin group (hazard ratio, 1.19; 95% CI, 0.85 to 1.66). Clinically relevant nonmajor bleeding occurred in 70 patients (1.6% per year) and 41 patients (0.9% per year), respectively.

CONCLUSIONS:

In patients with a recent history of embolic stroke of undetermined source, dabigatran was not superior to aspirin in preventing recurrent stroke. The incidence of major bleeding was not greater in the dabigatran group than in the aspirin group, but there were more clinically relevant nonmajor bleeding events in the dabigatran group. (Funded by Boehringer Ingelheim; RE-SPECT ESUS ClinicalTrials.gov number, NCT02239120.).

PMID:
31091372
DOI:
10.1056/NEJMoa1813959
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center